State Joins BMS Settlement Over Marketing Allegations

HARTFORD: Connecticut has joined a $19.5-million multi-state settlement with drug maker Bristol-Myers Squibb [NYSE: BMY] based in New York to resolve allegations that the company improperly marketed the antipsychotic drug Abilify.

A joint release by Attorney General George Jepsen and state Department of Consumer Protection (DCP) Commissioner Jonathan A. Harris announced the Connecticut’s share of the settlement funds is $310,133.

Of those settlement funds, $15,000 will be deposited in DCP’s Consumer Protection Fund and $15,000 will be deposited in the attorney general’s Consumer Protection Fund; both funds are used by the respective agencies to support investigations, training and consumer outreach efforts. The remaining settlement funds will be deposited in the state’s general fund.

Abilify is the brand name for the prescription drug aripiprazole, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2002 for the treatment of schizophrenia in adults.

The FDA has since approved Abilify in various formulations for several indications, including the treatment of bipolar disorder in certain children and adults, treatment of major depressive disorder in adults, and treatment of schizophrenia in certain children, among others.

The states allege, however, that Bristol-Myers Squibb promoted Ability for use in elderly patients with symptoms consistent with dementia and Alzheimer’s disease despite lack of FDA approval for this use and without establishing the drug’s safety. In 2006, the FDA issued a black-box warning for Abilify stating that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs have an increased risk of death.

The states also allege that Bristol-Myers Squibb marketed Abilify for children suffering from schizophrenia before it was approved by the FDA for children, and that the company minimized and misrepresented the risks associated with taking Abilify.